Associate Director, Clinical Operations

The Role:

The Associate Director, Clinical Operations leads and drives clinical trial(s) executional oversight in conjunction with Clinical Development and Project Management (PM) and across other functional areas for the clinical trial’s life cycle. This role may partner with the VP or Sr. Director Clinical Operations and Clinical Development to define overall strategy toward achieving/exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance. Lastly, the role may involve direct supervision and mentoring of clinical operations team members.

Key Responsibilities:

• Contributes to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
• Guides and supports trial management activities, including budget management, study management, CRO/Service Provider oversight, risk mitigation, and Good Clinical Practices
• Contribute to the CRO/vendor selection strategy to support assigned studies, collaborate with Procurement on the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies
• Escalate to VP or Sr. Director Clinical Operations as needed
• Supervise and direct clinical trial activities to ensure adherence to internal SOPs, as well as adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through the establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes
• May contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents.
• Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management, and mitigation.
• cross-functionally
• May provide input to the drafting of governance documents, SOPs, work instructions, and other resources
• May manage clinical operations assistants, including effective performance reviews, feedback, and development of staff

Requirements:

• Bachelors in Life Sciences with an advanced degree preferred
• 6-8 years of clinical research experience within a pharma, biotech or CRO, with at least 4 years leading a cross-functional drug development project team.
• Global experience working across all phases of clinical research (Phases 1-4)
• Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required
• Experience selecting and oversight of CROs/vendors required
• Experience in rare disease therapeutic areas and patient engagement strategies preferred
• Direct supervisory experience
• Strong interpersonal and negotiation skills
• Proven complex problem-solving and decision-making skills
• Must be a demonstrated self-starter and team player with strong interpersonal and communication skills
• Excellent written and verbal skills
• Must display strong analytical and problem-solving skills
• Unrelenting dedication to delivering quality results
• Integrity, in word and action
• Willingness to roll up your sleeves to get the job done
  
  

Work Environment:

• Remote-based; Immunovant’s headquarters is in NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (20%)